Protalix BioTherapeutics, Inc., a leading biopharmaceutical company focused on the development and commercialization of proprietary recombinant therapeutic proteins, recently announced that the company has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for prGCD, the company’s proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.
Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms. Protalix is currently conducting a Phase III pivotal study for prGCD to be used in enzyme replacement therapy for Gaucher disease.
This Fast Track Designation allows Protalix to file the sections of the New Drug Application (NDA) as they become available instead of filing all the sections at once as well as enables the agency to commence its review and proceed on a rolling basis as the additional sections are completed and submitted for review. In addition, the company has initiated a treatment protocol that allows physicians to treat Gaucher disease patients with prGCD in the United States and other countries worldwide while the drug is still under investigation.
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